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. 2020 Jun 2;2020(6):CD007568. doi: 10.1002/14651858.CD007568.pub2

Mosher 2016.

Study characteristics
Methods Setting: Indiana, USA
Recruitment: eligible participants were diagnosed with small cell or non‐small cell lung cancer; had at least 1 symptom of moderate severity, defined by validated cutoff points for depressive symptoms, anxiety, pain, vitality, or breathlessness; were fluent in English; and had a consenting carer
Randomisation: RCT; randomisation by a person not involved with study delivery using an SAS procedure
Participants 106 dyads comprising a man/woman with symptomatic lung cancer and his/her carer
Interventions Intervention: based on Social‐Cognitive Theory. Participants took part in four 45‐minute telephone symptom management (TSM) sessions. Both dyad members participated simultaneously through speaker phone. Received instruction in symptom management strategies. Mailed handouts detailing major points discussed during sessions, along with home practice assignments and digital media with instructions for relaxation exercises. Primary goal of intervention was to teach participants and carers evidence‐based cognitive‐behavioural and emotion‐focused strategies for managing symptoms. All sessions had dual focus on participant and carer concerns
Control group: four 45‐minute telephone sessions delivered to dyads by speaker phone aimed at directing participants to resources for practical health information and psychosocial services
Interventionist: clinical social workers trained by a PhD psychologist
Outcomes
  • Depression

  • Anxiety

  • Physical symptoms (pain, fatigue, breathlessness)

  • Self‐efficacy

  • Social constraints

  • Caregiver burden


Methods for assessing outcomes:
  • 8‐item Patient Health Questionnaire (PHQ‐8)

  • 7‐item generalized anxiety disorder scale (GAD‐7)

  • Brief Pain Inventory (BPI)

  • Fatigue Symptom Inventory

  • 4 items from the Memorial Symptom Assessment Scale (MSAS) to measure frequency and severity of breathlessness and associated distress

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Generated by an individual independent from the study. Stratified by participant gender and performance status
Allocation concealment (selection bias) Unclear risk No details
Blinding (performance bias and detection bias)
All outcomes Low risk Research assistants blind to study condition conducted all assignments by telephone
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Loss to follow‐up over 20%; reasons similar between groups
Selective reporting (reporting bias) Low risk Balanced reporting for all measures
Other bias Low risk The trial appears to be free of other problems that could put it at high risk of bias